MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D DEHP 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2420-0500

Device Problems Complete Blockage (1094); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown, device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ lvp 20d dehp 2ss cv tubing was kinked and did not allow flow.The following information was provided by the initial reporter: tubing was kinked and did not allow for flow.

Manufacturer Narrative

The following are potential lot numbers : d4: medical device lot #: 22075863.D4: medical device expiration date: 25jul2025.H4: device manufacture date: 25jul2022.D4: medical device lot #: 22075908.D4: medical device expiration date: 25jul2025.H4: device manufacture date: 25jul2022.The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 29-dec-2022.H6: investigation summary : one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.A kink was found below the drip chamber.The customer complaint that the tubing was kinked and did not allow for flow was verified.A quality notification was sent to the manufacturer.From the manufacturers investigation, the potential root cause for the kinked tubing is related to the tubing extrusion and tubing cutting processes.This reported failure mode was addressed in procedure changes that took effect on (b)(6) 2022.A device history record review for model 2420-0500 lot number 22075863 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 22075908 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the bd alaris¿ lvp 20d dehp 2ss cv tubing was kinked and did not allow flow.The following information was provided by the initial reporter: tubing was kinked and did not allow for flow.

• Brand Name: BD ALARIS¿ LVP 20D DEHP 2SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16056919
• MDR Text Key: 308487271
• Report Number: 9616066-2022-02072
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1